FILE PHOTO: A vial labelled with the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine is seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

Ben Burke Producer

U.S.

Pfizer touts vaccine safety for kids as young as 5 years old

Sep 20, 2021

Ben Burke Producer

By Ben Burke (Producer)

Pfizer announced Monday its COVID-19 vaccine is safe and effective for kids as young as five years old. The video above shows Pfizer Senior Vice President Dr. Bill Gruber discussing the announcement.

In a news release, Pfizer said it tested a much lower dose of its vaccine on kids in the 5-11 age group than what is currently available to people 12 years and older. Despite only getting about a third of the normal amount of the Pfizer vaccine, the 5-to-11-year-old kids developed coronavirus-fighting antibody levels just as strong as teenagers and young adults.

“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Pfizer Chairman and Chief Executive Officer Albert Bourla said.

Pfizer Senior Vice President Dr. Bill Gruber said the smaller dose of the vaccine was also safe for kids 5-11 years old. Side effects were similar to the effects teens experience, like sore arms, fever or achiness.

“I think we really hit the sweet spot,” Gruber said. He said Pfizer and BioNTech aim to apply for emergency use of its vaccine for kids 5-11 with the Food and Drug Administration by the end of the month. Earlier this month, FDA chief Dr. Peter Marks said once Pfizer turns over its study results, the FDA would evaluate the data “hopefully in a matter of weeks”.

Pfizer and BioNTech will apply with European and British regulators shortly after applying with the FDA.

“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Bourla said.

The announcement comes as most U.S. students are back in the classroom and cases in kids are skyrocketing.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination,” Bourla said.

Kids are at lower risk of severe illness or death than older people. However, more than 5 million children in the U.S. have tested positive for COVID-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics.

Tags: Pandemic

Dr. Bill Gruber, a Pfizer senior vice president and pediatrician: “I’m very pleased to announce that we have the first data that we’re going to be submitting to the FDA that demonstrates a robust immune response and satisfactory safety profile for the Pfizer-BioNTech mRNA vaccine in children five to 11 years of age.”

“We measure the ability of antibody from the children that were vaccinated to kill the virus and how well that matched up the antibody from 16 to 25 year olds, and it matched very closely. And since we know that 16 to 25 year olds are protected and antibody is a good measure of that protection, having matched that antibody response, we’re likely to match the protection.”

“Particularly in the setting of the delta variant, hospitals are seeing more pediatric cases. My understanding is that for those children that are hospitalized, a quarter of them are ending up in intensive care. Fortunately, deaths are uncommon, but nonetheless, this is a huge burden. But I’d like to remind people that it’s beyond the children that are getting sick and have the potential also to transmit to susceptible people in their home. It’s the nature of how this has conspired to interrupt the normal lives of children so they can get an education that’s unencumbered, that’s face to face, in person learning, that they can engage in typical activities inside and out of school. And although there have been inroads made by masking and doing other things, we’re still not where we need to be for children to be able to grow up and have a full childhood and all the way through adolescence. And so I see this as urgent for many reasons, the social reasons, as well as the immediate impact in reducing hospitalizations and illness.”

“We will plan to provide this information, start providing this information to the FDA by the end of this month.”

“We had more people volunteering quickly than we could accommodate in the trial. So there’s pent up demand for parents to be able to have their children return to a normal life to reduce the risk of their child getting sick as well as transmitting to the family. So I expect that you’ll see a rapid uptake amongst a high proportion of the population. Obviously, unfortunately, they’re just as there are among adults, there will be those that are reluctant. I think we have to do everything in our power to convince those individuals about the safety and effectiveness of the vaccine. But I expect uptake to be brisk.”